NCT05479305招募中不适用
Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Ceric Sàrl
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Primary Effectiveness Endpoints:
研究概览
简要总结
The study objectives are to assess safety and effectiveness, measured acutely and at the 30-day visit after implantation of the Valiant Captivia physician fenestrated Stent Graft.
Clinical utility measures throughout the procedure and until discharge will be assessed
详细描述
Prospective, single-arm, non-randomised, multicenter, investigator initiated clinical study evaluating subjects implanted with The Valiant Captivia physician fenestrated stent graft for the treatment of aneurysms/penetrating ulcers, Type B aortic dissections or residual dissection after Type A repair, of the aortic arch and the descending thoracic aorta which are candidates for revascularisation of all three supra-aortic vessels (BT (brachiocephalic trunk) , LCCA (left Common Carotid artery), LSA (Left Subclavian Artery)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •TAA/PAU (Thoracic Aortic Aneurysms and Penetrating Ulcers):
- •Subject is at least 18 years of age.
- •Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
- •Subject must be considered a candidate for revascularisation of BT, LCCA and LSA.
- •Subject must be able to tolerate surgical revascularisation of BT, LCCA and LSA.
- •Subject has a TAA/PAU which is:
- •a fusiform aneurysm with a diameter of ≥ 5.5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta; AND/OR
- •a saccular aneurysm or PAU (ulcer defined as ≥ 10 mm in depth and 20 mm in diameter, or symptomatic)
- •Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm
- •Subject has no thrombus in the proximal neck
- •Subject has a non-diseased aortic diameter between 25 mm and 42 mm and max diameter of the ascending aorta is ≤ 40 mm
- •Subject has a non-diseased LSA which is eligible for stent-grafting
- •Subject has sufficient landing zone within the LSA to accommodate the stent-graft without occlusion of any significant vessels
- •Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories.
- •Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft
- •Subject is affiliated with the social security system
- •Inclusion criteria:
- •TBAD(Type B Dissections) and Residual dissection after Type A repair:
- •Subject is at least 18 years of age.
- •Subject understands and has signed an Informed Consent approved by the Sponsor for this study.
- •a) Subject has a degenerative aortic arch aneurysm which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And/or b) Subject has a complicated TBAD (acute, subacute or chronic) which will require coverage of the LSA and extension of the proximal seal zone to zone 0 And/or c) Subject has a complicated residual dissection after replacement of the ascending aorta for type A aortic dissection which will require coverage of the LSA and extension of the proximal seal zone to zone 0
- •Subject has a healthy, non-diseased (without thrombus) aortic proximal seal zone of at least 20 mm
- •Subject has a healthy, non-diseased (without thrombus) aortic distal seal zone of at least 20 mm
- •Subject has a maximum diameter of the distal ascending aorta just above the BT of 40 mm
- •Subject has a non-diseased aortic diameter between 28 mm to 42 mm and the ascending aorta ≤ 40 m
- •Subject has a no atheromatous lesions int the arch and the BT, LCCA and LSA
- •Brachial, iliac or femoral artery access vessel morphology (diameter, calcification, tortuosity) that is compatible with vascular access techniques, the device, or accessories
- •Symptomatic patient who needs semi urgent repair; aptient is at high surgical risk and cannot wait for 6-8 weeks for a custom-made stent graft
- •Subject is affiliated with the social security system
排除标准
- •(Thoracic Aortic Aneurysms and Penetrating Ulcers, TAA/PAU):
- •Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
- •Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
- •Subject has an aneurysmal, tortuous, or atherosclerotic BT.
- •Subject has an ascending aorta diameter > 40 mm
- •Subject has thrombus in the proximal neck
- •Subject has an emergent need of treatment of the aortic pathology
- •Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites
- •Subject has circumferential calcification in the common femoral or external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.
- •Subject has an aortic atheroma classified as grade IV or grade V.
- •Subject has had previous endovascular repair of the ascending
- •Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise sealing of the device.
- •Subject is pregnant
- •Subject has a known allergy or intolerance to the device components.
- •Subject is in acute renal failure
- •Subject has a body habitus which prevents adequate visualisation of the aorta.
- •Subject has coronary artery disease with unstable angina and who has not received treatment.
- •Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
- •Subject has active systemic infection and/or a mycotic aneurysm.
- •Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observations of this study.
- •Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
- •Subject has a life expectancy of less than 2 years year.
- •Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
- •Subject has had previous surgical or endovascular treatment of an infra-renal aortic aneurysm <30 days of implantation of investigational device.
- •Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
- •Subject has had a cerebral vascular accident (CVA) within 3 months.
- •Subject has had a myocardial infarction (MI) within 3 months.
- •Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment
- •Exclusion criteria:
- •(Type B Dissections, TBAD and residual dissection after Type A repair):
- •Subject has an aneurysmal, tortuous, or atherosclerotic LCCA.
- •Subject has an aneurysmal, tortuous, or atherosclerotic LSA.
- •Subject has an aneurysmal, tortuous, or atherosclerotic BT.
- •Subject has a dissected BT and or LCCA
- •Subject has prohibitive calcification, occlusive disease, or tortuosity of intended sealing sites.
- •Subject has circumferential calcification in the common femoral artery, external iliac artery or in the common iliac artery with an intraluminal diameter (ID) less than 9 mm at any point proximal to or at the access vessel site unless a surgical adjunctive procedure is planned.
- •Subject has an aortic atheroma classified as grade IV or grade V.
- •Subject has had previous endovascular repair of the ascending, arch
- •Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal sealing sites that would compromise seal of the device
- •Subject is pregnant
- •Subject has a known allergy or intolerance to the device components
- •Subject is in acute renal failure
- •Subject has a body habitus which prevents adequate visualisation of the aorta.
- •Subject has coronary artery disease with unstable angina and who has not received treatment.
- •Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
- •Subject has active systemic infection and/or a mycotic aneurysm.
- •Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observationsof this study
- •Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
- •Subject has a life expectancy of less than 2 years.
- •Subject requires treatment of an infrarenal aneurysm at the time of the implantation.
- 另有 5 项未显示
结局指标
主要结局
Primary Effectiveness Endpoints:
时间窗: 30 days
The primary effectiveness endpoint is treatment success (defined below) and will be captured within the initial reporting period of 1 month from the index procedure. Treatment success defined as technical success comprising the following: * the successful delivery and deployment of the stent graft (The Valiant Captivia physician fenestrated Stent Graft) at the planned location * no unintentional coverage of supra-aortic vessels, assessed intra-operatively, * the removal of the delivery system * successful exclusion of the aortic lesion while maintaining patency of the LSA stent-graft as well as LCCA and BT at the 30-day visit
Primary Safety Endpoints:
时间窗: 30 days
Within one month (Day 0 - Day 30) from the index procedure, composite endpoint consisting of: * Aorta-Related Mortality * Stroke/TIA (Transient Ischemic Attack) * Paraplegia/paraparesis * Left Arm/Hand Ischemia
次要结局
- Intra/periprocedural through Discharge Clinical Utility Measures 1(0 to 30 days)
- Intra/periprocedural through Discharge Clinical Utility Measures 2(0 to 30 days)
- Intra/periprocedural through Discharge Clinical Utility Measures 4(0 to 30 days)
- Intra/periprocedural through Discharge Clinical Utility Measures 5(0 to 30 days)
- Secondary endovascular procedures(Up to 3 years)
- Intra/periprocedural through Discharge Clinical Utility Measures 7(0 to 30 days)
- Major adverse event(Up to 3 years)
- Intra/periprocedural through Discharge Clinical Utility Measures 6(0 to 30 days)
- Intra/periprocedural through Discharge Clinical Utility Measures 3(0 to 30 days)
- For TBAD, these additional observations will be evaluated(0 to 30 days)
- Secondary endovascular procedures for primary device failures(Up to 3 years)
- Other(Up to 3 years)
研究者
研究点 (8)
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